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| Sponsored by: |
Mahidol University |
|---|---|
| Information provided by: | Mahidol University |
| ClinicalTrials.gov Identifier: | NCT00712023 |
Purpose
The purpose of this study is to determine whether a custom-made forced-air warming mattress can prevent heat loss in patients undergoing vascular surgery better than a circulating-water mattress
| Condition | Intervention | Phase |
|---|---|---|
|
Hypothermia Vascular Surgery Forced-Air Warming Mattress Circulating-Water Mattress |
Device: warming device (a reusable, custom-made forced- air warming mattress) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Effect of Forced-Air Warming and Circulating-Water Mattress in Preventing Heat Loss During Vascular Surgery |
| Enrollment: | 44 |
| Study Start Date: | July 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
warming by circulating-water mattress
|
Device: warming device (a reusable, custom-made forced- air warming mattress)
2=forced-air warming mattress 1=circulating-water mattress
|
|
2: No Intervention
Forced-air warming mattress
|
A reusable, custom-made forced-air warming mattress was made of a light to medium weight water resistant canvas, sewn like mattress with 2 arms placed underneath the patient. An open hole at proximal part of one arm was designed to attach with a hose of warm air delivery device. Small holes (2-3 mm2), 5 inches apart were punched on the upper surface of this mattress around the patient except for the area underneath the patient that the holes were 9 inches apart. The weight of the patient will obstruct the air flow and prevent direct blowing of warm air onto the underside of patients. There is a special appendage connected to the upper part of mattress which can connect warm air to cover the patient's chest. There is a special appendage connected to the upper part of mattress which can convect warm air to cover the patient's chest. The mattress is 97 inches x 97 inches, with 2 arms of 25 inches x 16 inches and a special appendage of 45 inches x 12 inches for covering the chest with warm air delivery. This size is proper for patient of 170 cm. height. In order to reuse it, the mattress can be washed, dried and sterilized by gas or autoclaved for more than 50 times. A sterile sheet well enhance the sterile environment of the operating field.
Eligibility| Ages Eligible for Study: | 20 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Patients undergoing vascular surgery
Exclusion Criteria:
Preoperative fever
Contacts and Locations| Thailand | |
| Departnment of Anesthesiology,Siriraj Hospital, Mahidol University | |
| Bangkok, Thailand, 10700 | |
| Principal Investigator: | Suwannee Suraseraniwongse, MD | Mahidol University |
More Information
| Responsible Party: | Department of Anesthesiology, Siriraj Hospital, Mahidol University ( SUWANNEE SURASERANIVONGSE ) |
| Study ID Numbers: | Si 196/2007, 003(1)/50 |
| Study First Received: | May 14, 2008 |
| Last Updated: | February 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00712023 History of Changes |
| Health Authority: | Thailand: Ethical Committee |
|
Hypothermia Vascular surgery Forced-air warming mattress Circulating-water mattress |
|
Signs and Symptoms Hypothermia |
|
Signs and Symptoms Hypothermia Body Temperature Changes |
